FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0406-5116
11-digit product format
004065116
Labeler code
0406
Product ID
0406-5116_b4be564a-404d-4ca1-bac0-ec9cf40fef93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine Dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA211840
Marketing category
ANDA
Marketing start
2023-08-25
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
60 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211840-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25
A211840-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A211840-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A211840-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A211840-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A211840-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A211840-007LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A211840-001AB
A211840-002AB
A211840-003AB
A211840-004AB
A211840-005AB
A211840-006AB
A211840-007AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211840-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A211840-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A211840-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A211840-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A211840-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A211840-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A211840-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211840-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211840-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211840-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A211840-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A211840-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A211840-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A211840-007AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisdexamfetamine DimesylateLISDEXAMFETAMINE DIMESYLATESpecGx LLC806a1c15-0842-4787-b2ad-09a21fd96b372025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211840
application number: ANDA211840
ndc (product): 0406-5116

Additional Listing Data#

Finished product
Yes
Brand name base
Lisdexamfetamine Dimesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SJT761GEGSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854830Internal RxNorm lookup
854834Internal RxNorm lookup
854838Internal RxNorm lookup
854842Internal RxNorm lookup
854846Internal RxNorm lookup
854850Internal RxNorm lookup
1593856Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
806a1c15-0842-4787-b2ad-09a21fd96b37Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb29ac3a-860f-7ed2-7559-c97af4af1704Product name320250603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-5116-01Lisdexamfetamine Dimesylate100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-5116-01EA - Each0406-511653dafd50-5d03-4596-9a75-b86140d3f96d12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-5116LISDEXAMFETAMINE DIMESYLATE CAPSULE [SPECGX LLC]4Current NDC, 1 package rows20240807_806a1c15-0842-4787-b2ad-09a21fd96b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN806a1c15-0842-4787-b2ad-09a21fd96b375
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD806a1c15-0842-4787-b2ad-09a21fd96b375

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0406-5116-0100406511601100 CAPSULE in 1 BOTTLE (0406-5116-01) 100 capsule2023-08-25NoNoCurrent